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Inhibition Transcranial Random Noise Stimulation (inhibistim)

Primary Purpose

Impulsive Behavior, Inhibition

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial random noise stimulation (tRNS) (Starstim)
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulsive Behavior

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 18 and 45 years

Exclusion Criteria:

  • inability to give consent
  • Under 18 years
  • over 45 years
  • pregnant women
  • nursing mothers
  • History of neurological or psychiatric disorders and personality disorders in Cluster impulsivity (cluster B) according to Diagnostic and Statistical Manual (DSM) IV
  • french National Adult Reading Test (fNART): score below the 5th percentile
  • Contraindications to the practice of transcranial brain stimulation as international safety recommendations (Rossi et al., 2009)
  • Processing or recent psychotropic

Sites / Locations

  • Ch Le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham transcranial noise stimulation

1 Active transcranial random noise stimulation

3 Active transcranial random noise stimulation

Arm Description

subjects are stimulated 3 times with sham transcranial random noise stimulation (tRNS) (Starstim) with a 30 seconds offset

subjects are stimulated 1 time with active transcranial random noise stimulation (tRNS) (Starstim) at 2mA with a oscillatory frequency between 100 and 500 Hz during 20 minutes and 2 times with sham tRNS

subjects are stimulated 3 times with active transcranial random noise stimulation (tRNS) (Starstim) at 2mA with a oscillatory frequency between 100 and 500 Hz during 20 minutes

Outcomes

Primary Outcome Measures

Change in go no go test
errors and reaction times

Secondary Outcome Measures

Change in Stroop test
errors and reaction times
Change in Hayling test
errors and reaction times
Change in BIS 10
motor impulsivity, cognitive impulsivity, non planning impulsivity
Change in STAXI
score
Change in STAI
score
Change in EEG
occurrence of adverse effects

Full Information

First Posted
January 28, 2016
Last Updated
May 9, 2017
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02717260
Brief Title
Inhibition Transcranial Random Noise Stimulation
Acronym
inhibistim
Official Title
Inhibition Control Modulation by Transcranial Random Noise Stimulation (tRNS ) on the Prefrontal Cortex Measured by Change in Go no Test
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
September 29, 2016 (Actual)
Study Completion Date
September 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Inhibition control deficits is a major risk factor in the transition to the act in suicidal patients. Neuroimaging studies have shown that this failure was associated with hypoactivity in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was recently shown that a noninvasive brain stimulation session applied on the PFC reduces transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the activity and connectivity of neural network connected to the stimulation site. The investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC will allow a more intense and longer lasting effect on impulsivity and cognitive control in healthy volunteers compared to a single session and to placebo stimulation. The investigators assume that this behavioral change will be accompanied by a change in brain activity measured by resting EEG for the patients in the active group. A more intense and longer lasting effect is an essential step to transfer these results to patient populations. The main objective is to study the effect of bilateral stimulation of the PFC by transcranial random noise stimulation (tRNS) on the inhibition control measured by the cognitive motor inhibition capacity (Go NoGo test). The secondary objectives are to study the effect of tRNS on verbal inhibition (measured with the Hayling test); on anxiety (measured with the State-trait anxiety inventory (STAI)),on angry (measured with the State-trait anger expression inventory (STAXI)) on verbal and nonverbal inhibition (measured by the Stroop test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS 10)) and on the neuronal electrical activity measured by EEG.
Detailed Description
Subjects are stimulated 3 times in a day. Each 20 minutes stimulation are separated by a period of at least 30 minutes. Before and after each stimulation, inhibition is evaluated by cognitive tests (Go Nogo test, Stroop test, Hayling test) and by the BIS 10 scale. During the stimulation, subjects compleat the STAXI and STAI scales. Cognitive tests are repeated 24 hours and 8 days after the stimulation to evaluate duration of the effect. Possible side effects will be notified throughout the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior, Inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham transcranial noise stimulation
Arm Type
Sham Comparator
Arm Description
subjects are stimulated 3 times with sham transcranial random noise stimulation (tRNS) (Starstim) with a 30 seconds offset
Arm Title
1 Active transcranial random noise stimulation
Arm Type
Active Comparator
Arm Description
subjects are stimulated 1 time with active transcranial random noise stimulation (tRNS) (Starstim) at 2mA with a oscillatory frequency between 100 and 500 Hz during 20 minutes and 2 times with sham tRNS
Arm Title
3 Active transcranial random noise stimulation
Arm Type
Active Comparator
Arm Description
subjects are stimulated 3 times with active transcranial random noise stimulation (tRNS) (Starstim) at 2mA with a oscillatory frequency between 100 and 500 Hz during 20 minutes
Intervention Type
Device
Intervention Name(s)
transcranial random noise stimulation (tRNS) (Starstim)
Intervention Description
subjects are stimulated 3 times in a day by transcranial random noise stimulation (tRNS) (Starstim). each 20 minutes stimulation are separated by a period of at least 30 minutes. before and after each stimulation, inhibition is evaluated by cognitive tests: go nogo test, stroop test, Hayling test and by the BIS 10 scale. During the stimulation, subjects compleat the STAXI and STAI scales. Cognitive tests are repeated 24 hours and 8 days after the stimulation to evaluate duration of the effect. Possible side effects will be notified throughout the protocol.
Primary Outcome Measure Information:
Title
Change in go no go test
Description
errors and reaction times
Time Frame
15 minutes after the stimulation
Secondary Outcome Measure Information:
Title
Change in Stroop test
Description
errors and reaction times
Time Frame
15 minutes after the stimulation
Title
Change in Hayling test
Description
errors and reaction times
Time Frame
15 minutes after the stimulation
Title
Change in BIS 10
Description
motor impulsivity, cognitive impulsivity, non planning impulsivity
Time Frame
24 hours and 8 days after stimulations
Title
Change in STAXI
Description
score
Time Frame
24 hours and 8 days after stimulations
Title
Change in STAI
Description
score
Time Frame
24 hours and 8 days after stimulations
Title
Change in EEG
Time Frame
24 hours and 8 days after stimulations
Title
occurrence of adverse effects
Time Frame
8 days after stimulations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 18 and 45 years Exclusion Criteria: inability to give consent Under 18 years over 45 years pregnant women nursing mothers History of neurological or psychiatric disorders and personality disorders in Cluster impulsivity (cluster B) according to Diagnostic and Statistical Manual (DSM) IV french National Adult Reading Test (fNART): score below the 5th percentile Contraindications to the practice of transcranial brain stimulation as international safety recommendations (Rossi et al., 2009) Processing or recent psychotropic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAESEBAERT Frederic, MD PhD
Organizational Affiliation
HOPITAL VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Le Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Inhibition Transcranial Random Noise Stimulation

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